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Levorphanol (Levorphanol Tartrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Levorphanol Tartrate Tablets USP are indicated for the management of moderate to severe pain where an opioid analgesic is appropriate.

DOSAGE AND ADMINISTRATION

Oral

The usual recommended starting dose for oral administration is 2 mg. This may be repeated in 6 to 8 hours as needed, provided the patient is assessed for signs of hypoventilation and excessive sedation. If necessary, the dose may be increased to up to 3 mg every 6 to 8 hours, after adequate evaluation of the patient’s response. Higher doses may be appropriate in opioid tolerant patients. Dosage should be adjusted according to the severity of the pain; age, weight and physical status of the patient; the patient’s underlying diseases; use of concomitant medications; and other factors (see INDIVIDUALIZATION OF DOSAGE, WARNINGS and PRECAUTIONS). Total oral daily doses of more than 6 to 12 mg in 24 hours are generally not recommended as starting doses in nonopioid tolerant patients; lower total daily doses may be appropriate.

Use in Chronic Pain

The dosage of levorphanol in patients with cancer or with other conditions for which chronic opioid therapy is indicated must be individualized (see INDIVIDUALIZATION OF DOSAGE). Levorphanol is 4 to 8 times as potent as morphine and has a longer half-life. Because there is incomplete, cross-tolerance among opioids, when converting a patient from morphine to levorphanol, the total daily dose of levorphanol should begin at approximately 1/15 to 1/12 of the total daily dose of oral morphine that such patients had previously required and then the dose should be adjusted to the patient’s clinical response. If a patient is to be placed on fixed-schedule dosing (round-the-clock) with this drug, care should be taken to allow adequate time after each dose change (approximately 72 hours) for the patient to reach a new steady-state before a subsequent dose adjustment to avoid excessive sedation due to drug accumulation.

Note: As with all controlled substances, abuse by health care personnel is possible and the drug should be handled accordingly.

HOW SUPPLIED

Levorphanol Tartrate Tablets USP, 2 mg

White, scored tablets (Identified 54 410).

NDC 0054-0438-25: Bottles of 100 tablets.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP/NF.

DEA Order Form Required

10003340/04 Revised July 2011

©RLI, 2011

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